Abstract
Objective:
We hypothesized that, among parents of potential neonatal research subjects, an accompanying cover sheet added to the permission form (intervention) would increase understanding of the research, when compared to a standard form (control).
Study Design:
This pilot study enrolled parents approached for one of two index studies: one randomized trial and one observational study. A one-page cover sheet described critical study information. Families were randomized 1:1 to receive the cover sheet or not. Objective and subjective understanding and satisfaction were measured.
Results:
Thirty-two parents completed all measures (17 control, 15 intervention). There were no differences in comprehension score (16.8±5.7 vs 16.3±3.5), subjective understanding (median 6 vs 6.5), or overall satisfaction with consent (median 7 vs 6.5) between control and intervention groups (all P>0.50).
Conclusion:
A simplified permission form cover sheet had no effect on parents’ understanding of studies for which their newborns were being recruited.
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Acknowledgements
This research was supported in part by NICHD Bioethics Supplement 3U10HD068263-01S1, and is listed on clinicaltrials.gov, NCT01704560. We wish to thank the study coordinators, Elizabeth Werner, MPH, Tanya Scalise, RN, BSN, and Deanna Maffett, RN, the neonatal faculty and fellows and Christine Trahms, BS for their help. We thank the ‘Randomized Controlled Trial of the Effect Of Hydrocortisone on Survival Without Bronchopulmonary Dysplasia and on Neurodevelopmental Outcomes at 22–26 Months of Age in Intubated Infants <30 Weeks Gestation Age’ (‘Hydrocortisone’) subcommittee of the Eunice Kennedy Shriver National Institute of Child Health and Human Development’s Neonatal Research Network (NRN), which agreed to the use of the modified consent forms. We similarly thank the Rochester center investigators of the National Heart Lung and Blood Institute’s Prematurity and Respiratory Outcome Program (PROP) for allowing modified consent forms. We also thank the families who agreed to participate, without whom the work would not have been possible.
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D’Angio, C., Wang, H., Hunn, J. et al. Permission form synopses to improve parents’ understanding of research: a randomized trial. J Perinatol 37, 735–739 (2017). https://doi.org/10.1038/jp.2017.26
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DOI: https://doi.org/10.1038/jp.2017.26